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Data standards for tprovide a standardized way to describe those aspects of the planned conduct of a nonclinical study, as shown in the study design diagram examples within this section. The Trial Design Model in the SENDIG is equivalent to the Trial Design Model within the SDTMIG for clinical trials. Trial Design datasets contain study-level, rather than subject-level, information.

SEND

The he Trial Design Model in the SENDIG provides a standardized way to describe those aspects of the planned conduct of a nonclinical study, as shown in the study design diagram examples within this section. The Trial Design Model in the SENDIG is equivalent to the Trial Design Model within the SDTMIG for clinical trials. Trial Design datasets contain study-level, rather than subject-level, information. Note that generally the term "trial" is equivalent to "study" in the nonclinical context. In addition, "subjects" are equivalent to "animals."

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Modeling a nonclinical study in this standardized way requires the explicit statement of certain decision rules that may not be addressed or may not be as explicit in the textual description of the approved study protocol (or study plan). Prospective modeling of the design of a study could contribute to a more complete and wholly representative protocol. Retrospective modeling of the study design provides a reviewer with a clear description of how the study was conducted.

SDTM

ICH E3, Guidance for Industry, Structure and Content of Clinical Study Reports (available at http://www.ich.org/products/guidelines/), Section 9.1, calls for a brief, clear description of the overall plan and design of the study, and supplies examples of charts and diagrams for this purpose in Annex IIIa and Annex IIIb. Each Annex corresponds to an example trial, and each shows a diagram describing the study design and a table showing the schedule of assessments. The Trial Design Model provides a standardized way to describe those aspects of the planned conduct of a clinical trial shown in the study design diagrams of these examples. The standard Trial Design Datasets will allow reviewers to:

• Clearly and quickly grasp the design of a clinical trial
• Compare the designs of different trials
• Search a data warehouse for clinical trials with certain features
• Compare planned and actual treatments and visits for subjects in a clinical trial

Modeling a clinical trial in this standardized way requires the explicit statement of certain decision rules that may not be addressed or may be vague or ambiguous in the usual prose protocol document. Prospective modeling of the design of a clinical trial should lead to a clearer, better protocol. Retrospective modeling of the design of a clinical trial should ensure a clear description of how the trial protocol was interpreted by the sponsor.

Trial Design is applicable to both clinical and nonclinical studies.

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